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Divergence® Anterior Cervical Fusion System G6623513Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW PK2 G6623513 SA S-D 3.5mm x 13mm · Class 2 · Implant

All models of Divergence Anterior Cervical Fusion System (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169338788), received between Jul 18, 2019 and Jul 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Migration or Expulsion of Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 18, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

    PRE-OPERATIVE DIAGNOSIS: FRACTURE - DISLOCATION. PROCEDURE: ANTERIOR CERVICAL FIXATION LEVELS IMPLANTED: C5-6. IT WAS REPORTED POST-OP, THE IMPLANTED SCREW LOOSENED. IT WAS FOUND THAT THE ANGLE OF THE SCREW ON CAUDAL SIDE BECAME SHALLOWER AND CHANGED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8801645 ↗

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Sources and updates

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